EP3457948B1 - Dispositif de fermeture vasculaire - Google Patents

Dispositif de fermeture vasculaire Download PDF

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Publication number
EP3457948B1
EP3457948B1 EP17724070.2A EP17724070A EP3457948B1 EP 3457948 B1 EP3457948 B1 EP 3457948B1 EP 17724070 A EP17724070 A EP 17724070A EP 3457948 B1 EP3457948 B1 EP 3457948B1
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EP
European Patent Office
Prior art keywords
implant
sheath
aperture
certain embodiments
optionally
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
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EP17724070.2A
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German (de)
English (en)
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EP3457948A1 (fr
Inventor
Peter Grant
Bartosz PAWLIKOWSKI
Noelle Barrett
Mark MCGOLDRICK
Gerard Brett
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VIVASURE MEDICAL Ltd
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VIVASURE MEDICAL Ltd
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Publication of EP3457948A1 publication Critical patent/EP3457948A1/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A61B2017/0053—Loading magazines or sutures into applying tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Definitions

  • the present invention relates generally to closure systems and devices for use in surgical procedures.
  • Endoscopic surgery uses one or more scopes inserted through small incisions for diagnosing and treating disease.
  • endovascular surgery gives access to many regions of the body, such as the heart, through major blood vessels.
  • the technique involves introducing a surgical instrument percutaneously into a blood vessel, such as, for example, the femoral artery.
  • the currently emerging percutaneous endovascular procedures include aortic valve replacement, mitral valve repair, abdominal and thoracic aneurysm repair, and tricuspid valve replacement.
  • Other procedures requiring access to the femoral artery include coronary, carotid, and cerebral angiographic procedures.
  • Other procedures may require venous access, such as intravenous antibiotic treatment or long-term intravenous feeding for nutritional support.
  • NOTES Natural Orifice Translumenal Endoscopic Surgery
  • transgastric transvesical
  • transcolonic approaches e.g., transgastric, transvesical, and transcolonic approaches.
  • a key feature of these minimally invasive surgical procedures is the forming of a temporary pathway, usually an incision or dilated perforation, to the surgical site.
  • a temporary pathway usually an incision or dilated perforation
  • an access site e.g., incision, puncture hole, or perforation
  • Various instruments such as procedural sheaths, guidewires and catheters, are inserted through the access site, as well as specialized medical instruments, such as, balloon catheters, and stents.
  • the disclosure is directed to a device for sealing an aperture in a tissue, the device comprising: an implant configured to seal the aperture when positioned adjacent to the aperture and a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising: (i) a retaining sleeve comprising a locking projection engagable with the locking recess of the implant to secure the implant to the delivery shaft; (ii) a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement between the locking recess of the implant and the locking projection of the retaining sleeve, and a second axial position in which the release sleeve permits the locking projection of the retaining sleeve to disengage the locking recess of the implant;
  • the device is configured such that movement of the sheath cam from the first position to the second position (e.g., by rotation movement) causes (x) movement of the sheath carriage relative to the handle, causes (y) the movement of one end of the sheath into the handle, and causes (z) exposure of the implant in the vessel in an atraumatic way.
  • the interlocking projection is one of plurality of interlocking projections configured to engage a respective plurality of interlocking recesses of the implant.
  • the projection is biased toward a flared position such that movement of the release sleeve from the first axial position to the second axial position causes the interlocking projection to flare away from and out of engagement with the interlocking recess of the implant.
  • the device comprises: an actuator moveable between a first position and second position relative to the handle, wherein the device is configured such that (a) movement of the actuator from the first position to the second position (e.g., rotation movement) causes (a) a change in the position of two components of the implant relative to each other, and causes (b) the delivery shaft to release the implant.
  • an actuator moveable between a first position and second position relative to the handle, wherein the device is configured such that (a) movement of the actuator from the first position to the second position (e.g., rotation movement) causes (a) a change in the position of two components of the implant relative to each other, and causes (b) the delivery shaft to release the implant.
  • the delivery shaft and/or handle comprise a plurality of graphical markings and/or engravings (e.g., alphanumeric markings) indicative of an actuating sequence for use of the device (e.g., numbering to guide the user in the use of the device).
  • graphical markings and/or engravings e.g., alphanumeric markings
  • the delivery shaft and/or sheath comprise a plurality of graphical markings and/or engravings indicating sheath penetration (e.g., depth).
  • the implant is formed of a polymer adapted to remain shelf stable and functional for sealing after terminal sterilization.
  • the polymer is adapted to remain shelf stable and functional for sealing after terminal sterilization using at least one of (a) ethylene oxide, (b) electron-beam, (c) gamma irradiation, and (d) nitrous oxide.
  • the polymer is biodegradable.
  • the polymer comprises Polydioxanone, Poly-L-lactide, Poly-D-lactide, Poly-DL-lactide, Polyglycolide, ⁇ -Caprolactone, Polyethylene glycol, or combinations of these.
  • the polymer comprises polydioxanone.
  • the device is configured to seal a perforation in a hollow vessel.
  • the implant includes an intraluminal portion configured to form a seal with the perforation by contacting an intraluminal surface of the hollow vessel.
  • the implant includes an extra-luminal portion configured to extend outside the hollow vessel, the delivery shaft being configured to engage the implant via the extra-luminal portion.
  • the implant comprises a flexible wing extending outwardly from a base portion.
  • the device is configured to be guided over a guidewire.
  • the implant is formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g.
  • the implant comprises a flexible wing having a diameter greater than a diameter of the aperture in the tissue.
  • the implant comprises a distal foot portion, a flexible wing, and a recessed surface disposed in the distal foot portion and into which the flexible wing is positioned and crimped to provide an effective fluid seal between the foot portion and the flexible wing.
  • the crimping is achieved using at least one of (a) mechanical, (b) chemical, and (c) thermal methods.
  • the implant comprises: a flexible wing; and a foot including a distal portion configured to be disposed distally of the flexible wing when the implant is positioned to seal the aperture and a proximal neck configured to extend away from the aperture and proximally away from the aperture.
  • the distal portion of the foot has a length this is greater than a diameter of the aperture.
  • the proximal neck is flexible relative to the distal portion of the foot.
  • the proximal neck extends distally along an axis relative to an upper surface of the distal portion of the foot at an angle that is within the range from 10° to 70°.
  • the distal portion of the foot is configured to reinforce the flexible wing to facility sealing of the aperture.
  • the implant comprises a base portion and a pin moveable relative to the base portion between a first position and a second position, wherein the pin in the second position is configured to extend outwardly from the base to provide a safety against the base being fully pushed or pulled distally through the aperture to be sealed.
  • the implant includes a guide channel configured to receive a guide wire.
  • the pin is configured to block the guide channel when the pin is in the second position.
  • the pin is configured to leave the guide channel open when the pin is the second position.
  • the base includes a cavity configured to allow sealing of the guide channel via coagulation after removal of a guidewire from the guide channel.
  • the device further comprises: a loading funnel configured to fold the implant into an elongated folded configuration to permit the wing to pass through a procedural sheath when the delivery shaft maneuvers the implant into a location of the aperture to be sealed.
  • the loading funnel includes: a tapered portion configured to progressively fold the implant into the folded configuration when the implant is maneuvered through the tapered portion in a proximal direction; and a narrowed portion configured to receive the implant with the flexible wing in the folded configuration when the implant is maneuvered further in the proximal direction and proximally beyond the tapered portion.
  • the tapered portion comprises a frustoconical conical portion and the narrowed portion comprises a cylindrical portion.
  • the frustoconical portion and the cylindrical portion are non-concentric.
  • the narrowed portion comprises a cannula configured receive the implant with the wing in the folded configuration and that can be detached from the remainder of the loading funnel.
  • the device further comprises: a packaging having a proximal and a distal end, wherein the delivery shaft, the implant, and the loading funnel are disposed in the packaging such that the delivery shaft extends distally through the narrowed portion of the funnel and into the tapered portion, where the delivery shaft is coupled to the implant, and the loading funnel is held in the packaging such that proximal movement of the delivery shaft relative to the package causes, sequentially, (a) proximal movement of the implant through the tapered portion to progressively fold the implant into the folded configuration, (b) proximal movement of the implant into the cannula, and (c) separation of the cannula, with the implant disposed therein, from the remainder of the loading funnel.
  • a packaging having a proximal and a distal end, wherein the delivery shaft, the implant, and the loading funnel are disposed in the packaging such that the delivery shaft extends distally through the narrowed portion of the funnel and into the tapered portion, where the delivery shaft is coupled to the implant, and
  • the implant is held in the tapered portion by the delivery shaft a location.
  • the device further comprises a handle coupled to the delivery shaft, the handle being disposed in the packaging.
  • the cannula is configured to access multiple forms of introducer sheaths.
  • the disclosure is directed to a method of using the device described above, comprising: loading the implant in to the cannula at the time of a surgery in which the implant is used; and inserting the cannula into a proximal access of a procedural sheath in order to introduce the implant in the folded configuration into the procedural sheath.
  • the disclosure is directed to a device for sealing an aperture in a tissue, the device comprising: a sealing member configured to seal the aperture when positioned adjacent to the aperture; and a delivery device releasably coupleable to the sealing member such that the delivery device is configured to position the sealing member adjacent to the aperture, wherein the sealing member comprises a passageway configured to receive a guidewire to guide the sealing member to the aperture, the sealing member configured to seal the passageway after complete removal of the guidewire from the passageway; and a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising: (i) a retaining sleeve comprising a locking projection engagable with the locking recess of the implant to secure the implant to the delivery shaft; (ii) a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement
  • the disclosure is directed to a device for sealing an aperture in a tissue, the device comprising: a sealing member configured to seal the aperture when positioned adjacent to the aperture; and a delivery device releasably coupleable to the sealing member such that the delivery device is configured to position the sealing member adjacent to the aperture, wherein the sealing member comprises a passageway configured to receive a guidewire to guide the sealing member to the aperture, the sealing member configured to seal the passageway after complete removal of the guidewire from the passageway.
  • the sealing member comprises a base portion and a moveable member that is moveable between a first position and a second position relative to the base portion.
  • the sealing member is configured such that movement of the moveable member from the first position to the second position causes occlusion of the passageway in order to seal the passageway after removal of the guidewire from the passageway.
  • the delivery device is configured to move the moveable member from the first position to the second position.
  • example embodiments of the present disclosure provide surgical closure systems, devices, and methods.
  • provided systems, devices, and methods are useful for closing a perforation (e.g., a hole, puncture, tear, rip, or cut, etc.) in any hollow vessel associated with a mammalian surgical procedure.
  • a perforation e.g., a hole, puncture, tear, rip, or cut, etc.
  • the systems, devices, and methods are useful for closing a perforation in any lumen of a mammal, including, for example, the gastrointestinal tract (e.g., the stomach, intestines, colon, etc.), heart, peritoneal cavity, esophagus, vagina, rectum, trachea, bronchi, or a blood vessel.
  • Some embodiments of the present disclosure are directed to a closure system, device, and method of percutaneous closure of an arteriotomy following an endovascular/intra-arterial procedure.
  • an aspect of example embodiments of the present disclosure is to provide systems, devices, and methods that allow seal to be formed closure of a tissue perforation in a reliable manner with minimal trauma to the luminal tissue, for example, by providing a sutureless seal.
  • the fibrous adventitial layer of an artery i.e., the outer layer
  • the intimal and endothelial layers are friable.
  • an arteriotomy may be circumferential in nature and perpendicular to the longitudinal axis of the artery.
  • FIG. 1 depicts a pictorial image of an embodiment of the device in an unloaded state.
  • the device comprises the parts listed in Table 1 below; the functionality of each part is described in further detail below.
  • Table 1 Part Name Detail Introducer unit Sheath and Dilator Sheath Sheath shaft, sheath hub, haemostasis valve and sheath retainer Dilator Dilator shaft and dilator hub
  • Loading Funnel Protects implant in packaging and facilitates implant loading
  • Lever Maintains attachment of loading funnel to loading cannula Cannula Cannula tube, cannula seal, cannula cap and cannula retainer Cannula tube Protects the implant during insertion through the sheath seal Cannula seal Seal in the cannula cap Cannula retainer Locks cannula tube and cannula seal inside the cannula cap Cannula cap Houses the cannula tube and cannula seal Sheath carriage Connects to cannula Handle front L Operator grip area of the device Handle front R Operator grip area of the device Handle centre Join
  • a delivery system e.g., as described herein, is packaged in a tray system, e.g., with the implant located in the loading funnel.
  • the device is held by the back handle section and pulled to a physical and tactile feel stop in the tray (see, e.g., FIG. 3 ).
  • the implant is loaded into a (loading) cannula assembly (the cannula assembly and its components are described below).
  • a funnel lever is then unlatched from the (loading) cannula cap, and the device is withdrawn from the tray in a backward motion leaving the funnel and lever in the tray (see FIGS. 4A-C ).
  • the loading funnel is designed so as to ensure that the implant is folded concentrically (e.g., in an overlapping manner) as the implant is withdrawn backward into and/or through the funnel and loaded into the cannula (see, e.g., FIGS. 5A-B ).
  • the introducer unit comprises a sheath and dilator (see, e.g., FIGS. 6A and 6B , and FIGS. 7A-7D ), and may have shafts of varying lengths, diameters, and/or French sizes.
  • the introducer unit comprises a graduated scale on the sheath shaft (or sheath outer shaft) and a blood signal in the dilator shaft.
  • these provide the operator with visual indicators of relative location of the introducer and the device delivery system during initial deployment of the sheath to the, e.g., arteriotomy, and again during the deployment of the implant.
  • the graduated scale on the sheath shaft and the blood signal allow the operator to identify the position of the implant during deployment, and to deploy the implant in the correct or desired location.
  • the dilator loads onto and/or travels over a guide wire (e.g., a 0.035" (0,9 mm) guide wire), which occupies the internal diameter of the dilator at the distal tip and proximal hub areas.
  • the dilator contains a blood signaling hole in the hub which is fed from a blood signal hole located in close proximity (e.g., just distal) to the sheath tip, e.g., on the tapered portion of the dilator.
  • the introducer unit e.g., sheath and dilator
  • the introducer unit e.g., sheath and dilator
  • blood enters the dilator at the blood signal hole (e.g., as soon as the blood signal hole on the distal tip of the dilator enters a blood vessel), and travels up the dilator's lumen, and exits the dilator at a signal hole (e.g., a blood signal detector hole) on the dilator hub.
  • a signal hole e.g., a blood signal detector hole
  • the graduations on the sheath shaft can then provide to the operator an indication of the tissue tract depth, as this point on the graduated scale (at the skin level) indicates the depth of the tissue tract (mark X).
  • the introducer unit is advanced by a certain distance (4 cm) into the vessel to mark Y (going by the graduated scale on the sheath).
  • the dilator is subsequently removed from the sheath, while maintaining the sheath at the 'Y' location in the vessel, and keeping the guidewire in its relative position.
  • the sheath hub is designed to connect with the dilator hub using, e.g., a spring clip mechanism (see, e.g., FIGS. 8A-8C ) or a bayonet mechanism (see, e.g., FIGS. 8D-8F ), wherein the dilator hub is pushed into the sheath hub and, e.g., engaged (e.g., clicked) and/or twisted to lock in position ( FIG. 8F ).
  • a spring clip mechanism see, e.g., FIGS. 8A-8C
  • a bayonet mechanism see, e.g., FIGS. 8D-8F
  • tabs on the distal end of a spring clip mechanism latch onto, e.g., pockets on the sheath hub, holding both hubs firmly together.
  • one or more proximal end or ends of a clip or clips is/are compressed, causing on or more tabs to exit their corresponding pocket on the sheath hub, allowing the dilator to be withdrawn from the sheath (see, e.g., FIGS. 8A-8C ).
  • the sheath hub is also designed to connect with the cannula.
  • the haemostasis valve is secured into the sheath hub by the sheath retainer (see, e.g., FIGS. 9A and 9B ).
  • the sheath retainer has snap features which align with snap features on the cannula cap to facilitate connection and locking into position (see, e.g., FIGS. 10A-10D ).
  • the cannula or cannula assembly includes a cannula cap, cannula tube, cannula seal, and cannula retainer (see FIGS. 11A-11D ).
  • the components can be seen, e.g., in FIGS. 12A and 12B .
  • the cannula is part of the distal tip of the delivery device. In certain embodiments, the cannula is not part of the distal tip of the delivery device.
  • the implant is loaded into the cannula from its resting position in the device tray packaging. In certain embodiments, during the first steps of implant deployment, the cannula is connected to the hub of the introducer sheath.
  • the delivery device is advanced towards the introducer sheath hub and the implant is delivered down to a position just proximal to the distal tip of the introducer sheath.
  • the cannula engages and locks into the introducer sheath hub to form a single unit.
  • the implant is loaded into the cannula, which is assembled onto a tip of a shaft of the device.
  • the shafts of the device are advanced to push the implant out of the cannula to the end of the sheath.
  • the (cannula) seal functions to stop the blood from flowing out the back of the cannula along the shaft during deployment of the device.
  • Sheath withdrawal (handle front, sheath carriage, cannula and sheath)
  • the delivery handle is moved into close proximity to the introducer sheath hub.
  • the cannula is designed to enter and lock and/or fit securely into the handle of the device.
  • the cannula (connected to the sheath) is moved back and connected into the sheath carriage inside the handle front as shown in FIG. 13 and FIG. 14 .
  • a sheath cam is engaged with the sheath carriage and is then rotated from a first position ( FIG. 14 ) to a second position, e.g., clockwise 180° which in turn actuates the sheath carriage and pulls back the sheath into the handle front (see FIG. 15 ).
  • the result of this action is, for example, to expose the implant in the vessel in an atraumatic way by pulling the introducer sheath assembly in the proximal direction relative to the delivery handle.
  • the user then (e.g., gradually) withdraws the device and sheath (assembly) (e.g., fully or partially) together from the artery (or other vessel, such as a vein), watching the graduations on the sheath until the mark X is reached.
  • the user when the mark X on the graduated scale is reached, the user can feel the sheath tip exit the arteriotomy (or other vessel incision or access point) and within a certain distance (e.g., 1.5 cm) further withdrawal, can feel a back pressure as a result of the implant anchoring itself against the inside of, for example, a lumen of an artery wall (or other vessel, such as a vein) (this is the tamponade position).
  • a certain distance e.g. 1.5 cm
  • the handle end houses the release sleeve hub, the retainer sleeve hub, and the push tube hub (see FIG. 16 ).
  • the retainer sleeve hub remains stationary while (a) the push tube hub moves forward, which deploys a retention member (e.g., a pin), and (b) the release sleeve hub moves back to release the implant.
  • these hub movements are actuated by depressing the cam lock (3) and rotating the back cam (4) clockwise 180° from a first position (see FIG. 17 ) to a second position (see FIG. 18 ).
  • the hub movements e.g., depressing the cam lock (3) and rotating the back cam (4)
  • the hub movements can be actuated only after the guidewire is fully retracted from the device.
  • the hub movements e.g., depressing the cam lock (3) and rotating the back cam (4)
  • the delivery shaft and/or handle comprise a plurality of graphical markings and/or engravings (e.g., alphanumeric markings) indicative of an actuating sequence for use of the device (e.g., numbering to guide the user in the use of the device).
  • the methods and devices described herein can provide a system for the delivery of an implant from its assembly through transportation and storage, and ultimately during all stages of implant deployment into an aperture in a hollow vessel, e.g., an opening in a vessel wall that the implant is intended to seal.
  • An exemplary implant is described hereinbelow and in U.S. Patent Application No. 13/781,628 , ( US2014/0018846A ).
  • an implant can be delivered through an introducer sheath into a hollow vessel (such as an artery or a vein) within which there had been made an access hole to perform a minimally invasive procedure.
  • a hollow vessel such as an artery or a vein
  • the graduated sheath in conjunction with the blood signaling dilator can provide a positional indication of the implant.
  • Exemplary applications of the methods and devices described herein include: Closing access site holes in hollow vessels; closing access site holes in blood vessels; closing holes in arteries or veins; closing small and large holes up to 30F in hollow vessels; closing access site holes in the abdominal cavity post endoscopic procedures; or closing access site holes in the femoral artery, subclavian artery, ascending aorta, axillary and brachial arteries.
  • the methods and devices described herein include a system for delivering an implant in the correct positional location during closure of holes in a blood vessel, and a tool to successfully deliver an implant to close large holes in blood vessels in patients who have diseased vessels and who may have plaques and/or calcified lesions near the access site.
  • an implant comprise a foot including a distal portion configured to be disposed distally beyond a distal surface of the tissue when the device is in a sealing position, and a proximal portion configured to extend proximally through the aperture and proximally beyond a proximal surface of the tissue when the device is in the sealing position; a flexible wing positionable against the distal surface of the tissue adjacent the aperture such that the flexible wing is disposed between the anterior distal portion of the foot and the distal surface of the tissue when the device is in the sealing position; and an elongated retention member supported by the proximal portion of the foot, the retention member moveable with respect to the proximal portion from a first position to a second position such that a portion of the tissue is disposed between the retention member and the flexible wing when the device is in the sealing position.
  • implant device components e.g., the foot core 20, the flexible wing 60, and the extra-luminal pin 80, 80a in the illustrated examples of FIG. 19A to 19C
  • implant device components are manufactured from synthetic absorbable materials, although other suitable non-synthetic and/or non-absorbable materials may be used instead of, or in addition to, these synthetic absorbable materials.
  • the flexible wing 60, the foot core 20, and the extra-luminal pin 80, 80a may each be manufactured from any suitable material, e.g., Polydioxanone (PDO), Poly-L-lactide (PLLA), Poly-D-lactide (PDLA), blend of D-lactide and L-lactide, i.e.
  • PDO Polydioxanone
  • PLLA Poly-L-lactide
  • PDLA Poly-D-lactide
  • blend of D-lactide and L-lactide i.e.
  • any one or more of the components of the implant device 5, 5' may be formed of any suitable material.
  • the components of the device 5 may be made of the same or different materials relative to each other.
  • the flexible wing may be manufactured as a thin sheet, it may also be made of a woven material, e.g., using electrospinning, weaving and knitting processes.
  • FIGS. 19A to 19C represent each of these components in situ.
  • the arteriotomy seal is achieved in large part by the hydraulic haemodynamic pressure, which acts on the flexible wing 60 to force the flexible wing 60 against the luminal surface and conform to the luminal topography to seal around the arteriotomy.
  • FIGS. 20A to 20D show the assembled implant 5 showing three components - foot core 20, flexible wing 60, and extra-luminal pin 80.
  • the example illustrated in FIGS. 20A to 20D consists of three pieces, it should be appreciated that more or few pieces may be provided.
  • the flexible wing 60 may be integrally formed with the foot 20 as a single, monolithic piece.
  • FIGS. 20A and 20C show the implant 5 after proximal retraction of the guidewire 150 and subsequent extension, or deployment, of the extra-arterial pin 80 to its distal, or deployed, position relative to the foot core 20.
  • FIGS. 20A and 20C show the implant 5 with the extra-luminal pin 80 in a retracted or undeployed state
  • FIGS. 20B and 20D show the extra-luminal pin 80 in a distally extended or deployed state.
  • the foot core 20 includes both an intra-luminal section 25 which is configured to be maintained in the interior of the artery 2, or other tissue structure, when the implant 5 is in situ, and an extra-luminal section 40 which passes through the arteriotomy across the arterial wall when the implant 5 is in situ.
  • the intra-luminal section 25 and the extra-luminal section 40 are separated at a recess 22, which is configured to receive the wing 60 such that a cylindrical recessed surface 23 is maintained inside a circular central cut-out or aperture 65 in the wing 60.
  • the aperture 65 is illustrated, for example, in FIGS. 24A and 24B .
  • intra-luminal and “extra-luminal” may be referred to as “intra-arterial” and “extra-arterial” in the context of the illustrated embodiments, it being understood that the arteriotomy-closure application is non-limiting and the closure of any suitable tissue aperture may be performed by example embodiments of the present disclosure.
  • the extra-luminal section 40 of the foot core 20 is provided in the form of a neck 42 which extends from the intra-luminal section 25 at an angle, e.g., selected from a range from 10° to 70°, and has five primary functions:
  • the intra-luminal section 25 of the foot core 20 has a primary function to provide a rigid scaffold to support the flexible wing 60.
  • the underside of the intra-luminal section 25 may be concave in cross-section to reduce its profile within the artery 2 and has a hollow entry portion or port 52 of the guidewire channel 50 adjacent the neck 42, shown in the sectioned foot core 20 of FIG. 21D .
  • FIGS. 22A to 22F show another foot core 20a.
  • This configuration has a circular intra-luminal portion 25a in plain view and a concave surface 30a which is concave in cross-sectional profile within the artery 2.
  • FIGS. 23A to 23B show another foot core 20b having an intra-luminal portion 25b that is generally rectangular in plain view and includes a concave bottom surface.
  • the flexible wing 60 is a thin disc sized to be larger than the arteriotomy diameter (arteriotomy diameter is equivalent to the outer diameter of the delivery/procedural sheath 100).
  • the central hole 65 and disc portion are circular in shape, in plain view. It should be understood, however, that other geometries may be provided for the hole and/or the disk portion of the wing 60.
  • the central hole 65 is sized to accept recessed cylindrical surface 23 within the foot core 20's flexible-wing retention recess 22 shown, e.g., in FIGS. 21A and 21B , and is free to rotate relative to the foot core 20 about the concentric axis of the recessed cylindrical surface 23.
  • FIG. 24A shows the flexible wing 60 in its flat and relaxed state
  • FIG. 24B shows the flexible wing 60 in its curved state, which corresponds to the final configuration within the artery 2.
  • the curvature of the wing 60 shown in FIG. 24B corresponds to the curvature of the interior of the artery to which the wing 60 conforms in its final implanted state.
  • the wing 60 is pressed against the artery interior wall by hemodynamic hydraulic pressure exerted by the blood in the artery 2.
  • the wing 60 is flat, or planar, in its relaxed state, it should be appreciated that the wing 60 may be curved or have any other suitable geometry in its relaxed state.
  • the flexible wing 60 is positioned within the artery 2 against the luminal surface 3 adjacent the arteriotomy and held in this position with the aid of the hemodynamic hydraulic pressure it acts as the primary seal around the arteriotomy to control bleeding.
  • the wing 60 is illustrated slightly pulled away from the luminal surface 3 only to facilitate illustration.
  • the flexible wing 60 In addition to elastically deforming to conform to the luminal surface 3 of the artery 2, the flexible wing 60 also elastically deforms to fit within the procedural sheath 100 for delivery into the artery 2. This is achieved by rolling the wing 60 into a cylinder-like configuration. Once within the artery 2, and beyond the procedural sheath 100, the flexible wing 60 intrinsically recovers towards its flat state to allow the hemodynamic hydraulic pressure in the artery 2 to conform the wing 60 to the shape of the arterial luminal and surface topography 3. In this regard, the elasticity of the wing 60 allows the wing 60 deform locally at differing areas of the luminal surface 3 of the artery 2. This allows the wing 60 to conform to local irregularities along the surface 3 to ensure that the arteriotomy is adequately sealed despite such irregularities.
  • the flexibility of the wing 60 is not just important in a lateral configuration to facilitate collapse during delivery, but it is also important to flex in a longitudinal plane. Flexibility in both lateral and longitudinal planes is important to ensure an effective seal around the arteriotomy of arteries in differing disease states with different surface topographies and varying anatomical configurations. Longitudinal flex is facilitated by the configurations shown, e.g., in FIGS. 20A - 23B , by the flexible wing 60 and the foot core 20 being separate and distinct parts that are non-fixedly mated together.
  • the wing 60 since the wing 60 is not fixed to the foot 20, it is able to separate from the upper surface of the relatively rigid intra-luminal portion 25 of the foot core 20 at regions where the topography of the arterial surface 3 deviates or is disposed at a greater distance from the upper surface of the intra-luminal portion 25 than at adjacent regions of the surface 3.
  • the wing 60 has a circular outer periphery, it should be understood that the wing 60 may be provided with any suitable geometry. Further, although the wing 60 has a uniform thickness, it should be understood that the wing 60 may be provided with a thickness that varies at different regions of the wing 60. For example, the wing 60 could have a thickness in its central region that is greater than a thickness toward the circumferential periphery of the wing 60.
  • FIGS. 25A and 25B shows an assembled implant 5 in cross section.
  • FIG. 25A shows the implant 5 in a state where the guidewire 150 would be in situ.
  • FIG. 25B shows the deployed implant 5.
  • the extra-luminal pin 80 is a safety feature of the closure system to prevent the implant being pushed off the luminal surface by application of extracorporeal pressure above the implantation site or due to patient movements.
  • the extra-luminal pin 80 in the illustrated example does not generally contribute to or form part of the sealing function of the implant 5.
  • the implant 5 will seal the arteriotomy in the absence of the extra-luminal pin 80 in accordance with some example embodiments.
  • the extra-luminal pin 80 is deflected parallel to the artery 2 wall as it is advanced, as illustrated, e.g., in FIG. 25B . This deformation of the extra-luminal pin 80 helps secure it in its post deployment position.
  • the pin 80 is also maintained in this position via a press fit between the proximal portion 82 of the pin and the proximal recess 47 of the foot core 20 into which the proximal portion 82 is pressed.
  • the extra-luminal pin 80 may also be used to occlude the guidewire hole within the foot core 20 when deployed, e.g., in a configuration such as illustrated in FIGS. 25A and 25B , the pin 80 being illustrated in isolation in FIG. 25C .
  • an enlarged proximal portion 82 of the extra-luminal pin 80 blocks the guidewire channel 50.
  • the pin 80 In its proximal or retracted position, the pin 80 allows the guidewire 150 to pass through channel 83 in the enlarged proximal portion 82.
  • the channel 83 does not align with the channel 50 in the foot core 20, thereby blocking the channel 50.
  • the guidewire In the proximal or retracted position, the guidewire is able to pass through both channels 50 and 83 since the channels 50 and 83 are sufficiently axially spaced apart.
  • any other suitable mechanism may be provided for closing the guidewire channel 50.
  • the formation of coagulated blood in the conically shaped entry portion 52 of the guidewire channel 50 The coagulated blood would then be pressed and locked into the narrowing conical geometry of the entry portion 52 by the hydraulic pressure exerted by the blood in the artery 2.
  • the guidewire 150 may be left in place for, e.g., several minutes (e.g., 4 to 5 minutes). The presence of the guidewire may, during this period, induce sufficient clotting of the blood to form the closure in the entry portion 52. Then, upon retraction of the guidewire 150, the coagulated blood would compress and collapse to fill the void left by the removal of the guidewire 150.
  • FIG. 25D an alternative extra-luminal pin 80a is shown with an additional slot 85a to facilitate the pin 80a being moved into its distal or extended position whilst the guidewire 150 remains in place.
  • the pin 80y may be used to occlude the guidewire hole within the foot core 20y when deployed.
  • a loading funnel aligns an implant for loading into a loading cannula.
  • an implant is loaded during device removal from the packaging tray.
  • a short device reduces potential for movement whilst achieving tamponade, resulting in faster deployment times.
  • a user can position a hand on the patient during use, thus experiencing less fatigue.
  • rotational actuations are employed to deploy the device.
  • a custom made introducer can be supplied in varying French sizes with the device, which can enable device to be used to close various size holes in arteries or veins.
  • a blood signal on the dilator in conjunction with graduations on the introducer shaft provides the user with an indication of tissue tract depth, which is utilized in identifying the positional location of the implant for achievement of tamponade and subsequent deployment of the implant.
  • the methods and devices described herein can provide an indication to the user when to expect tactile feel when achieving tamponade during deployment. In certain embodiments, less force is required to load the device into its delivery profile (i.e., reducing its cross-sectional profile in preparation for delivery) as the loading cannula internal diameter is enlarged.
  • the methods and devices described herein can reduce the chance of accidental pull-out of the implant as the user is aware of, e.g., the arteriotomy or other vessel (e.g., a vein) access location.

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Claims (15)

  1. Dispositif destiné à fermer une ouverture de manière étanche dans un tissu, le dispositif comprenant :
    a. un implant (5) configuré pour fermer l'ouverture de manière étanche quand il est positionné adjacent à l'ouverture ; et
    b. un arbre de délivrance configuré pour entrer en prise avec l'implant pour permettre que l'implant (5) soit manœuvré en une prise étanche avec une surface distale du tissu, l'arbre de délivrance comprenant :
    (i) un manchon de retenue comprenant une saillie de verrouillage capable d'entrer en prise avec un évidemment de verrouillage de l'implant (5) pour fixer l'implant (5) à l'arbre de délivrance ;
    (ii) un manchon de délivrance capable de coulisser de manière axiale par rapport au manchon de retenue entre une première position axiale dans laquelle le manchon de délivrance est configuré pour maintenir la prise de verrouillage entre l'évidemment de verrouillage de l'implant (5) et la saillie de verrouillage du manchon de retenue, et une deuxième position axiale dans laquelle le manchon de libération permet que la saillie de verrouillage du manchon de retenue sorte de la prise avec l'évidemment de verrouillage de l'implant ; et
    (iii) une poignée couplée à l'arbre de délivrance, caractérisé en ce que ladite poignée comprend (a) une came de fourreau (4) capable de mouvement entre une première position et une deuxième position par rapport à la poignée, et (b) un chariot de fourreau connecté à un fourreau,
    dans lequel le dispositif est configuré de sorte que le mouvement de la came de fourreau (4) de la première position à la deuxième position dans un mouvement de rotation entraîne (x) le mouvement du chariot de fourreau par rapport à la poignée, entraîne (y) le mouvement d'une extrémité du fourreau jusque dans la poignée, et entraîne (z) l'exposition de l'implant (5) dans le vaisseau d'une manière non traumatique.
  2. Dispositif selon la revendication 1, dans lequel la saillie de verrouillage est l'une d'une pluralité de saillies d'interverrouillage configurées pour entrer en prise avec une pluralité respective d'évidements d'interverrouillage (45) de l'implant (5).
  3. Dispositif selon les revendications 1 ou 2, dans lequel la saillie de verrouillage est sollicitée vers une position évasée de sorte que le mouvement du manchon de délivrance de la première position axiale à la deuxième position axiale amène la saillie d'interverrouillage à s'évaser en s'écartant de et en sortant de la prise avec l'évidemment de verrouillage (45) de l'implant (5).
  4. Dispositif selon l'une quelconque des revendications 1 à 3, comprenant en outre :
    un actionneur capable de mouvement entre une première position et une deuxième position par rapport à la poignée, dans lequel le dispositif est configuré de sorte que le mouvement de l'actionneur de la première position à la deuxième position par un mouvement de rotation entraîne (a) un changement de position de deux composants de l'implant l'un par rapport à l'autre, et amène (b) l'arbre de délivrance à libérer l'implant (5).
  5. Dispositif selon l'une quelconque des revendications 1 à 4, dans lequel l'implant (5) est formé d'un polymère conçu pour rester stable à la conservation et fonctionnel pour une fermeture étanche après la stérilisation terminale, facultativement le polymère est conçu pour rester stable à la conservation et fonctionnel pour une fermeture étanche après la stérilisation terminale en utilisant au moins l'un (a) d'un oxyde d'éthylène, (b) d'un faisceau d'électrons, (c) d'une irradiation aux rayons gamma, et (d) d'un oxyde nitreux, facultativement le polymère est biodégradable, facultativement le polymère comprend de la Polydioxanone, du Poly-L-lactide, du Poly-D-lactide, du Poly-DL-lactide, du Polyglycolide, de la ε-Caprolactone, du Polyéthylène glycol, ou des combinaisons de ceux-ci, facultativement le polymère comprend de la polydioxanone.
  6. Dispositif selon l'une quelconque des revendications 1 à 5, dans lequel le dispositif est configuré pour fermer de manière étanche une perforation dans un vaisseau creux.
  7. Dispositif selon l'une quelconque des revendications 1 à 6, dans lequel l'implant (5) inclut une partie intraluminale (25) configurée pour former une fermeture étanche avec la perforation en entrant en contact avec une surface intraluminale (3) d'un vaisseau creux (2).
  8. Dispositif selon l'une quelconque des revendications 1 à 7, dans lequel l'implant (5) inclut une partie extraluminale (40) configurée pour s'étendre à l'extérieur du vaisseau creux, l'arbre de délivrance étant configuré pour entrer en prise avec l'implant via la partie extraluminale.
  9. Dispositif selon l'une quelconque des revendications 1 à 8, dans lequel l'implant (5) comprend une aile souple (60) s'étendant vers l'extérieur à partir d'une partie de base.
  10. Dispositif selon l'une quelconque des revendications 1 à 9, dans lequel le dispositif est configuré pour être guidé sur un fil de guidage (150).
  11. Dispositif selon l'une quelconque des revendications 1 à 10, dans lequel l'implant (5) est formé au moins en partie d'un matériau ayant une viscosité inhérente comprise dans une plage de 0,5 à 7,0 dl/g.
  12. Dispositif selon l'une quelconque des revendications 1 à 11, dans lequel l'implant (5) comprend une partie pied distale (20), une aile souple (60), et une surface évidée (23) disposée dans la partie pied distale (20) et dans laquelle l'aile souple (60) est positionnée et sertie pour fournir une fermeture étanche aux fluides efficace entre la partie pied (20) et l'aile souple (60), le sertissage est facultativement obtenu en utilisant au moins un procédé parmi des procédés (a) mécaniques, (b) chimiques, et (c) thermiques.
  13. Dispositif selon l'une quelconque des revendications 1 à 12, dans lequel l'implant (5) comprend : une aile souple (60) ; et un pied (20) incluant une partie distale configurée pour être disposée de manière distale par rapport à l'aile souple (60) quand l'implant (5) est positionné pour fermer l'ouverture de manière étanche et un cou proximal (42) configuré pour s'étendre à l'écart de l'ouverture et de manière proximale par rapport à l'ouverture, facultativement la partie distale du pied (20) a une longueur qui est supérieure à un diamètre de l'ouverture, facultativement le cou proximal (42) est souple par rapport à la partie distale du pied (20), facultativement le cou proximal (42) s'étend de manière distale le long d'un axe par rapport à une surface supérieure de la partie distale du pied (20) à un angle qui est dans les limites de la plage de 10° à 70°, facultativement la partie distale du pied (20) est configurée pour renforcer l'aile souple (60) pour faciliter la fermeture étanche de l'ouverture.
  14. Dispositif selon l'une quelconque des revendications 1 à 13, dans lequel l'implant (5) comprend une partie de base et une broche de retenue (80) capable de mouvement par rapport à la partie de base entre une première position et une deuxième position, dans lequel la broche (80) dans la seconde position est configurée pour s'étendre vers l'extérieur à partir de la base pour s'assurer que la base ne soit pas entièrement poussée ou tirée de manière distale à travers l'ouverture devant être fermée de manière étanche.
  15. Dispositif selon la revendication 14, dans lequel l'implant (5) inclut un canal de guidage (50) configuré pour recevoir un fil de guidage, facultativement la broche (80) est configurée pour bloquer le canal de guidage (50) quand la broche (80) est dans la deuxième position ou la broche (80) est configurée pour laisser le canal de guidage (50) ouvert quand la broche (80) est dans la deuxième position, facultativement la base inclut une cavité configurée pour permettre la fermeture étanche du canal de guidage (50) via la coagulation après le retrait d'un fil de guidage (150) du canal de guidage (50).
EP17724070.2A 2016-05-20 2017-05-18 Dispositif de fermeture vasculaire Active EP3457948B1 (fr)

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US201662339638P 2016-05-20 2016-05-20
US201662343573P 2016-05-31 2016-05-31
PCT/EP2017/062035 WO2017198789A1 (fr) 2016-05-20 2017-05-18 Dispositif de fermeture vasculaire

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EP3457948A1 (fr) 2019-03-27
WO2017198789A1 (fr) 2017-11-23
US20170333014A1 (en) 2017-11-23
US11278269B2 (en) 2022-03-22
CN108495590B (zh) 2022-04-01
US20220160341A1 (en) 2022-05-26
CN108495590A (zh) 2018-09-04

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